(Senior) Principal Clinical Pharmacology Lead

THE POSITION

As Clinical Pharmacology Lead you act in global development teams with a responsibility for the Clinical Pharmacology development package.

You work in a department (Translational Medicine & Clinical Pharmacology) bridging the path from early research to submission interacting with multiple functional areas within BI.

You have the choice to work at the Ingelheim site in close proximity to Frankfurt am Main or the Biberach site in the southern part of Germany close to the Alpes and Lake Constance.

This position can be filled in Ingelheim or Biberach

Tasks & responsibilities as Principal Clinical Pharmacology Lead

• As Principal Clinical Pharmacology Lead, you will represent Clinical Pharmacology (Clin. in BI project teams as well as in internal or external initiatives or working groups.
• You will provide expertise to the overall pre-clinical and clinical drug development of new drug candidates, in particular the design and oversight over the whole clinical pharmacology development including support of formulation development / biopharmaceutical aspects.
• You will provide input into clinical development plans, clinical study protocols and reports, Investigator’s Brochures and the ClinPharm section of INDs, CTA’s, NDAs / BLAs or respective label text.
• You will be accountable for all ClinPharm aspects of a compound in early and late-stage clinical drug development towards regulatory authorities worldwide in one of Boehringer Ingelheim’s core therapeutic areas of Oncology, Cardio-Renal & Metabolism, CNS or Retinal Health.
• You will be part of medical and R&D development teams throughout the development.

Additional tasks & responsibilities as Senior Principal Clinical Pharmacology Lead

As Senior Principal Clinical Pharmacology Lead you will additionally take a leading role in implementing and promoting innovative methodologies and approaches, and provide training and expert advice to junior colleagues and interfaces.

Requirements as Principal Clinical Pharmacology Lead

• in Pharmaceutical Sciences or other life sciences with
• Advanced knowledge of Clinical Pharmacology aspects in drug development such as Pharmacokinetics & Pharmacodynamics (PK / PD) principles, Biopharmaceutics, and Clinical Pharmacology aspects in patient trials, incl.

special populations such as pediatrics

Thorough understanding of pre-clinical and clinical drug metabolism, PK / PD, drug-drug / food interactions; working knowledge in pharmacokinetic software programs incl.

understanding of modeling tools . PBPK

• Thorough knowledge on Clinical Pharmacology related guidelines from the main regulatory agencies
• Basic knowledge in biomarkers, pharmacogenomics, and biostatistics
• Excellent oral and written communication, negotiation, and presentation skills

Additional requirements as Senior Principal Clinical Pharmacology Lead

• Distinct social and leadership skills
• Great sense of responsibility and interest in interdisciplinary work
• Demonstrated comprehensive knowledge of the drug development process
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